EU/3/21/2517: Orphan designation for the treatment of follicular lymphoma

Mosunetuzumab

Overview

This medicine was designated as an orphan medicine for the treatment of follicular lymphoma in the European Union on 12 November 2021.

This means that the developer will receive scientific and regulatory support from EMA to advance their medicine to the stage where they can apply for a marketing authorisation.

Orphan designation does not mean the medicine is available or authorised for use. All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.

During the medicine's development, doctors may be able to enrol patients in clinical trials investigating the medicine. For information on ongoing clinical trials in the EU, see:

Key facts

Active substance
Mosunetuzumab
Intended use
Treatment of follicular lymphoma
Orphan designation status
Positive
EU designation number
EU/3/21/2517
Date of designation
12/11/2021
Sponsor

Roche Registration GmbH
Emil-Barell-Strasse 1
Grenzach
79639 Grenzach-Wyhlen 
Baden-Wuerttemberg
Germany
Tel. +49 7624 14 2892
E-mail: global.eu_regulatory_office@roche.com

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Lunsumio at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.

More information is available in the PDF icon orphan medicine assessment report .

Update history

DateUpdate
June 2022Mosunetuzumab has been authorised in the EU as Lunsumio since 3 June 2022.

Documents related to this orphan designation evaluation

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

EU register of orphan medicines

The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

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